Self-administered Flu Vaccines: The Potential of Microneedle Patches

March 11, 2014 - Needle phobia--also known as belonephobia--has been recognized by the Diagnostic and Statistical Manual of Mental Health Disorders since the 1990s, and mental health experts believe that over 10 percent of the population is impacted by the fear.

In fact, this aversion to needles, combined with a time-consuming trip to the health clinic or doctor’s office, causes many people to avoid getting important medical care such as an annual flu vaccine.

This sequence of photographs shows how microneedle patches can be self-administered to a person’s forearm. (Georgia Tech Photo: Gary Meek)

But new research published in the journal Vaccine indicates that these factors could cease to be a problem, as traditional needles and clinician-administered vaccinations could potentially be replaced by self-administered vaccine patches.

Mark Prausnitz, PhD, a Regent’s professor in the School of Chemical and Biomolecular Engineering at the Georgia Institute of Technology, along with other researchers and scientists from Georgia Tech, Emory University and the Centers for Disease Control and Prevention (CDC), recruited 91 adults from the Atlanta area to participate in a study to determine microneedle patch usability and acceptability. They found that users could not only correctly apply prototype microneedle patches, but self-administration may also increase overall influenza vaccination rates.

These patches can empower patients to self-administer drugs that would otherwise require them to go to a clinic and seek out a nurse or other health care professional, Prausnitz explained.

“We have studied this particularly in the context of flu vaccinations, where millions of Americans and people around the world are supposed to get a flu shot every year,” Prausnitz said. “It’s a major burden on the health care infrastructure to administer all of the shots, and our feeling is that it’s a reasonable proposition that people might be able to administer those shots themselves.”

The prototype patches have microscopically small needles that puncture the skin and thereby deliver the vaccine into the body in a way that is easy for people to do: the patches require no training, they aren’t scary, and they induce little or no pain. The study participants were given minimal instruction on how to apply the placebo patches.

“The conclusion was that people were able to it and able to do it well,” he said. “It gave us confidence that this delivery method is one suitable for self-administration.”

In addition to evaluating how well the participants were able to apply the patches, researchers also had participants assess the pain associated with patch application as compared to traditional needle injections. On a scale of one to 100, study participants rated the patches 1.5 on average, while the injection was rated 15.

Another component of the study was that we asked people if they plan to get a flu shot in the next year, and a little under half said yes, Prausnitz explained. “We then said, ‘Well, what if you have the option of having your flu vaccination done with a microneedle patch, would that change your mind?’ We had an increase in 19 percentage points in terms of the fraction of people who said they would get vaccinated if a patch were available to them.”

When choosing between hypodermic needles with syringes and microneedle patches for vaccination, researchers found that patients were much more likely to choose the patches. (Georgia Tech Photo: Gary Meek)

The microneedle patches increased intent to vaccinate from 44 percent to 65 percent, and 64 percent of participants intending vaccination would prefer to self-vaccinate.

Prausnitz believes self-administration of microneedle vaccine patches will impact health care broadly by empowering patients and reducing the workload on nurses and other clinicians who typically administer vaccinations, allowing them to use their expertise in other areas.

The microneedle patches used in the study were placebos and did not contain any medication, but Prausnitz said they will be conducting a Phase 1 clinical trial of the patch with the vaccine in it directly compared to intramuscular vaccination to find out if it is safe and immunogenic in people. “Beyond that, we hope then to partner with a pharmaceutical company and bring it forward to Phase 2 and 3 trials, and ultimately as a product people can use.”

This was the first-in-humans study of microneedle patch usability and acceptability. Prausnitz and his team are also working with other organizations on self-administered microneedle patch vaccines beyond influenza, including polio and measles. The National Institutes of Health (NIH) has supported research on microneedle patches for influenza vaccinations and Prausnitz said several leading organizations including 3M, Zosano, and Australia-based Vaxxas are making strides in microneedle technology development.

“There are two key features of the microneedle patch as opposed to a hypodermic needle, and one of them is that it is not a needle--it’s not a scary and painful needle. The other is that it enables self-administration. We predicted that more people would be willing to be vaccinated if they had the patch, but we thought the real driver on that was going to be the self-administration. They don’t have to bother waiting in line, getting a shot and taking time out of their day to do that,” Prausnitz concluded. “But it turned out the bigger driver for people was no needles. The critical factor for getting people to say ‘I will get vaccinated’ was the lack of the hypodermic needle.”